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influenza antigen test
Differential diagnosis:
- influenza
Specimen:
- nasal aspirate or wash, naspharyngeal swab (obtain from lab)
Method:
- turn around time 30 minutes
Clinical significance:
- test will distinguish influenza A & B
- negative test does NOT exclude influenza infection
- tests might not detec virus at low concentrations [3]
- specificity = 98% but sensitivity = 54% in adults & 67% in children [2]
- variable results among 11 different diagnostic tests [3]
- positive test does NOT exclude coinfection with another pathogen
- viral culture suggested for suspected influenza infection when influenza antigen test is negative
Notes:
- office-based tests performed poorly during 2009 H1N1 pandemic
- FDA proposes regulation to meet quality control specifications [4]
Related
avian flu/acute respiratory virus testing
influenza
General
clinical microbiology test
References
- Veterans Administration
- Chartrand C et al
Accuracy of Rapid Influenza Diagnostic Tests: A Meta-analysis
Annals of Internal Medicine February 21, 2012, 156(4)
PMID: 22371850
http://www.annals.org/content/early/2012/02/27/0003-4819-156-7-201204030-00403.abstract
- Centers for Disease Control and Prevention
Evaluation of 11 Commercially Available Rapid Influenza
Diagnostic Tests -- United States, 2011-2012
MMWR, November 2, 2012 / 61(43);873-876
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6143a3.htm
- Executive Summary
Proposed Reclassification of the Rapid Influenza Detection Tests
CDRH Microbiology Devices Advisory Committee Meeting
June 13, 2013, Gaithersburg, Maryland
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM356185.pdf